Indications For Use - CooperSurgical Kronner Manipujector 6003 Mode D'emploi

6003 • Kronner Manipujector
(D) Luer Lock
(H)
Depth
Markings
(I) Rear Edge
(G) Spring Loaded
Pinch Clamp
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a physician.
DESCRIPTION
The Kronner Manipujector
sterile, disposable, double lumen device made of clear polyvinyl chloride. The double-
lumen tube is 33 cm (13") long; has an OD (Outside Diameter) of 5 mm, and is marked
along the tube segment from the rear of the handle. The insertion depth (H) is marked
from 5-10 cm in 1 cm increments. Surrounding the distal end but not covering the tip is
an inflatable balloon (A) which is inflated using a standard syringe (not included) via an
inflation valve and pilot balloon assembly (B). The distal tip (C) is open to allow the
introduction of appropriate media into the uterus. The media can be passed through the
inner injection lumen via a luer lock connector (D) with a syringe (not included). The
curved non-removable sliding rigid handle (E) has a molded cervical stop (F) at the
distal end and a spring loaded pinch clamp (G) on the proximal end.
Firmly squeezing the pinch clamp allows the cervical stop to be positioned at the
desired measured depth. When released, the spring loaded pinch clamp forces a pin
into the hard wall of the catheter preventing any movement of the handle once it is in
the desired position. The balloon is inflated in the uterus and is retracted against the
internal os. By advancing the cervical stop firmly against the cervix, the instrument will
maintain a secure, trauma-free hold on the uterus. The operator can then safely
manipulate the uterus and inject media into the uterus without reflux through the
cervical canal.

INDICATIONS FOR USE

The Kronner Manipujector (Uterine Manipulator-Injector) is indicated for use during
those procedures requiring manipulation of the uterus such as minilap tubal ligation,
laparoscopic tubal occlusion, diagnostic laparoscopy or operative laparoscopy. It is also
an efficient intrauterine injector that effectively seals the internal cervical os against the
cervical back-flow of fluid or gas during its injection through the device's central lumen.
As such it can be used in laparoscopic tubal patency studies such as chromotubation
and in selected patients for such a procedure as hysterosalpingography.
Instructions for Use (English)
(E) Sliding Rigid Handle
(Uterine Manipulator-Injector) is a gently curved, single-use,
®
Uterine Manipulator-Injector
®
1
(F) Cervical Stop